The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States.
The purpose of a NDA is to provide enough information to permit the FDA to reach the following key decisions:
- Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.
- Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.
- Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.
Latest New Drug Applications
APF530 (granisetron)
Company: A.P. Pharma, Inc.
Treatment for: Nausea/Vomiting -- Chemotherapy Induced
APF530 is a long-acting formulation of granisetron being developed for the prevention of chemotherapy-induced nausea and vomiting.
تعليقات
إرسال تعليق